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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF73, 12X100 KII FIOS ZTHR 6/BX GCJ

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APPLIED MEDICAL RESOURCES CTF73, 12X100 KII FIOS ZTHR 6/BX GCJ Back to Search Results
Model Number CTF73
Device Problem Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/21/2018
Event Type  Malfunction  
Manufacturer Narrative

The event unit was not returned to applied medical for evaluation. As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed. In the absence of the event unit, it is difficult to determine the exact root cause of the event. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products. This report represents the initial and final report.

 
Event Description

Procedure performed: prostatectomy with da vinci robot. Event description: the ctf73 trocar was used as camera port (da vinci si laparoscope port) during prostatectomy. When inserting the laparoscope into the trocar the laparoscope did not get through the seal housing. The laparoscope then was pushed with force through the seal housing and the port was used during the whole surgery but every time the laparoscope was pulled out for cleaning and inserted into the trocar again this was done by force due to the high friction. Unfortunately the trocar was thrown away but the lot number was saved. The same incident happened on monday during the same type of surgery with da vinci but both the trocar and the lot number were thrown away. [reference mw #2027111-2018-00151]. Additional information received from the sales rep by email on 26 mar 2018: patient status is without remark since the patient was not affected of this. The only remark would be that the surgery time was a little bit longer due to the problem with the seal housing. Additional information received from the sales rep by email on 4 apr 2018: da vinci si robot laparoscope was used. There is only one size which is more than 10 mm. Type of intervention: a ctf73 trocar from the same lot was used on same purpose and procedure on the same day but there was not any problems. Patient status: no patient injury or illness occurred associated with the complaint event.

 
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Brand NameCTF73, 12X100 KII FIOS ZTHR 6/BX
Type of DeviceGCJ
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
wendy kobayashi
22872 avenida empresa
rancho santa margarita, CA 92688
9497138059
MDR Report Key7422460
MDR Text Key105655597
Report Number2027111-2018-00150
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeSE
PMA/PMN NumberK041795
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/24/2020
Device MODEL NumberCTF73
Device Catalogue Number101219101
Device LOT Number1308716
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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